Product Donation Supports Clinical Study to Evaluate FDA-Approved Medications for Mild-to-Moderate COVID-19 in Outpatients

WESTON, Fla., Oct. 7, 2021 /PRNewswire/ - Apotex Corp. has donated a total of 25,000 fluvoxamine tablets and placebo tablets to the Duke Clinical Research Institute for the ACTIV-6 clinical study funded by the National Institutes of Health (NIH) to evaluate repurposed medications in the search for effective, safe treatments for mild-to-moderate COVID-19 for non-hospitalized patients.

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is approved by the Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder and other conditions, including depression. According to NIH, further studies are needed to establish whether the anti-inflammatory effects of fluvoxamine observed in nonclinical studies are also seen in COVID-19 clinical studies. Many small-scale studies have shown positive therapeutic benefits of fluvoxamine, including a recent Canadian study that saw fluvoxamine curb the number of COVID-19 patients ending up in hospital by 30 per cent¹.

ACTIV-6 is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding up development of the most promising treatments and vaccines for COVID-19.

A selection committee of clinical, industry and government experts determine which medications to investigate. Fluvoxamine is among existing FDA-approved medications chosen for ACTIV-6 to further evaluate its effects on mild-to-moderate COVID-19.

"With the surge of the delta variant and a footprint in the United States, our dedication to putting patients first remains utmost. We are proud to support a clinical trial that has the potential to support millions of Americans," said Peter Hardwick, President & CEO, Apotex Corp. "Through our flexible supply chain model, we are able to adjust our manufacturing and distribution schedules to ensure this donation does not impact patients who currently rely on these essential, everyday medicines."

ACTIV-6, "The Randomized Trial to Evaluate Efficacy of Repurposed Medications," is a double-blind study expected to enroll nearly 15,000 participants. Potential participants are at least 30 years old, have tested positive for COVID-19 and are experiencing symptoms. They may enroll in the study from anywhere in the United States through the ACTIV-6 website, https://activ6study.org, and call center, 833-385-1880. Participation involves taking the medication and keeping track of symptoms over 90 days through online surveys.

About Apotex Corp.

Apotex Corp. is a US based company, headquartered in Weston, Florida.  It and its global affiliates are leaders in generic pharmaceuticals and biosimilars and are committed to supplying patients with a broad portfolio of high-quality, affordable medicines covering all major therapeutic areas.

¹ https://healthsci.mcmaster.ca/news-events/news/news-article/2021/08/13/anti-depressant-can-save-covid-patients-says-mcmaster-led-study

SOURCE Apotex Corp.